NCT06056271Recruiting
Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation
Volta Medical
Start Date
3/19/2024
Completion Date
12/1/2027
Summary
Observational, multi-center, clinical device registry for US patients with a primary goal to observe the clinical outcomes in patients who are mapped with Volta Medical's VX1 or AF-Xplorer systems during AF ablation procedures.
Eligibility Criteria
Age Range: 21 years to No maximum
Inclusion Criteria:
1. Patients 21 years of age or older who is:
* indicated for AF ablation or
* Who has received an AF-ablation with the past 24 months where VX1 was used or
2. Patients are receiving or received a catheter ablation procedure for AF according to current guidelines
3. Patients must be able and willing to provide written informed consent to participate in the clinical trial
Exclusion Criteria:
1. Patients not indicated or were not indicated for catheter ablation according to current guidelines
2. Patients with AF secondary to an obvious reversible cause
3. Patients who are or may potentially be pregnant
4. Enrollment in an investigational study evaluating another non-VX1 investigational device, biologic, or drug
Interventions
DEVICE
AF Ablation
Conditions
Atrial Fibrillation
Locations
Endeavor Health
Evanston, Illinois 60201
United States
Kansas City Cardiac Arrhythmia Research LLC
Overland Park, Kansas 66211
United States
Northwell Health
New York, New York 10075
United States
Ohio State University
Columbus, Ohio 43210
United States